Orthopedic medical device

ABSTRACT

Disclosed is an orthopedic medical device which includes an orthesis structure which is made of a rigid or semi-rigid material or it is made of an elastically yielding material and has at least one external wall to be anchored to a face or wall of an orthopedic guardian adapted to directly or indirectly contact an area of a body limb or body part to be protected.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention refers, in general, to an orthopedic medicaldevice. More particularly, the present invention refers to an orthopedicmedical device for a universal use in fixed or mobile orthopedicguardians as well as in the therapy of foot pathologies.

Description of the Related Art

As is known, in the use of fixed or mobile orthopedic guardians ingeneral, and in particular prostheses, orthopedic corsets, knee-guards,orthopedic knitted correctors, collars, wristbands, helmets and thelike, pathologies of orthopedic type are possible.

In the treatment of said pathologies as well as in the therapy of footpathologies it is possible to use orthopedic guardians, plantar soles orother similar devices which are subjected to modifications or simplewear and tear in the long run.

Owing to alterations such as a formation of decubitus zones orcompression zones, or yielding in the articulations or in the loadingpoints of the foot, said orthopedic guardians or plantar soles are nomore tolerated by the patient or user because the patient or user feelsso sharp pains (plantalgies) that are unbearable.

In order to solve said problem, the patient or user has to substitutethe used orthopedic guardian or plantar sole repeatedly by a new device.

Thus, there is the need of intervening effectively and rapidly in orderto predispose a different orthesis anatomy without substituting ordestroying the orthopedic guardian or medical podotherapic devicealready predisposed or worn by the patient or user.

SUMMARY OF THE INVENTION

An object of the invention is to remove the above-mentionedinconveniences and still others through an orthopedic medical devicethat ensures a wide possibility of varying, reconstructing or, in anycase, modifying the orthesis anatomy of an orthopedic guardian, amedical podotherapic device or the like, also with an immediate orgradual intervention according to the evolution of the therapy in courseand without interruptions in the treatment.

Another object of the invention is to provide a medical orthopedicdevice ensuring an optimal adaptability of an orthesis anatomyobtainable also for subsequent approximations, according to the specificrequirements of each single case, in decubitus and compression zonescausing pain or in zones that need to be isolated and protected.

Another object of the invention is to provide a medical orthopedicdevice that is washable and/or sterilizable and/or replaceable and iscapable of ensuring the maintenance of hygienic conditions in eachintervention area or otherwise positionable in order to be adapted to achanged condition of the area to be protected.

All the above-mentioned objects and still others are reached accordingto the invention through an orthopedic medical device which comprises anorthesis structure which has at least one external wall to be anchoredto a face or wall of an orthopedic guardian adapted to directly orindirectly contact an area of a body limb or bodypart to be protected.

In the medical orthopedic device according to the present invention, theorthesis structure comprises, preferably, at least one external wallwhich is anchored removably to the face of the orthopedic guardian.

Preferably, the at least one external wall comprises a layer of graspingor graspable material which grasps or is grasped to said face of theorthopedic guardian which comprises a graspable or grasping material,respectively.

According to a preferred embodiment, the external wall comprisesremovable male or female engaging means which cooperate with removablefemale or male engaging means, respectively, which are provided on theface of the orthopedic guardian.

Advantageously, the orthopedic medical device is at least partiallyconfigured as an orthesis map with removable zonal islands and orthesesfor the formation of anatomical discharges and/or inserts.

According to a preferred embodiment, the orthesis structure comprises alayered structure consisting of at least one supporting layer and atleast one diecut layer defined by removable islands or zones.

According to this last embodiment, preferably said supporting layercomprises a diecut layer and a covering element in a graspable material,joined to each other. In particular, said diecut layer comprises:

-   -   a grasping layer turned toward the graspable material of the        diecut layer for a removable fixing;    -   a layer of soft or rigid or semirigid material,    -   a covering layer.

Said diecut layer and said covering element are jointed to each other incorrespondence of the peripheral edge of the hollow punch.

Typically, the orthesis structure is in a rigid or semi-rigid orelastically yielding material.

The layers of grasping material, soft, rigid or semirigid material andcovering material are bound or coupled together.

BRIEF DESCRIPTION OF THE DRAWINGS

Further features and details of the invention will be better understoodfrom the following specification which is provided by way of anon-limiting example, as well as from the annexed drawings, wherein:

FIG. 1 is a plan view of a plantar sole bearing an orthesis elementaccording to the invention;

FIG. 2 is a side view of the plantar sole in FIG. 1;

FIG. 3 is a view in section in a slightly enlarged scale taken along thetrace in FIG. 1;

FIG. 4 represents another embodiment of the plantar sole, an orthesiselement according to the invention being applied thereon,

FIG. 5 is a view in section and in an enlarged scale taken along thetrace V-V in FIG. 4;

FIG. 6 is a perspective view of an orthesis element to be anchored in aremovable way to a plantar sole according to the invention;

FIG. 7 represents a plan view of another embodiment of an orthesisstructure made of an elastically yielding material to be anchored in aremovable way to a plantar sole according to the invention;

FIG. 8 is a view in section taken along the trace VIII-VIII in FIG. 7;

FIG. 9 shows another embodiment of a mobile orthesis element made of asemirigid material;

FIG. 10 represents a view in section taken along he trace X-X in FIG. 9;

FIG. 11 is a partial plan view of the calcaneal portion of anotherembodiment of the plantar sole according to the invention;

FIG. 12 shows a section taken along the trace XII-XII in FIG. 11;

FIG. 13 shows a first embodiment of the plantar sole having an orthesismap;

FIG. 14 is a view in section and in an enlarged scale taken along thetrace XIV-XIV in FIG. 13;

FIGS. 15, 16 and 17 shows respective embodiments of plantar soles havingan orthesis map;

FIG. 18 is a partial view in section and in an enlarged view taken alongthe trace XVIII-XVIII in FIG. 17;

FIG. 19 shows another embodiment of a plantar sole having an orthesisplan;

FIG. 20 is a view in partial section and in enlarged scale taken alongthe trace XX-XX in FIG. 19; and

FIG. 21 is a perspective view of a shoe with an internal calcanealorthesis band according to the invention, provided with one or morecorrective buttresses.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

With reference to the annexed drawings, reference number 1 denotes aplantar sole 1 on the whole which is formed by a support 2 whichconsists of one or more layers of a suitable material such as cardboard,leather, plastic material, and in case shaped so as to be adapted to thefoot anatomy, as is usual in the shoe manufacture, as well as a coveringlayer 3 which covers at least its face, which is designed to support thefoot of the user, the covering layer 3 being formed, for example, by afabric, a non-woven fabric, or the like, and is glued to the support 2.

One or more orthesis elements or inserts 4 can be applied to thecovering layer 3 and have the desired anatomic configuration. Eachorthesis element or insert consists of one or more layers or bodies orglobes of a rigid material (which may be formed by or may include metalelements or metallic alloys, for example copper, aluminum, orferromagnetic components), or a semi-rigid material such as leather,wood, cork, PVC (polyvinylchloride), polypropylene, polyethylene,polyesther, ETV, EVA (ethylvinylacetate), polyvinylacetate, acrylicmaterials and soft, elastically yielding materials such as rubber,elastomeric cork-rubber plastic materials, polyethylene sponge, rubbersponge with opened cells and/or microcellular rubber sponge, silicone,felts and the like, and at least one external wall applied thereto so asto be applied removably to the face or wall 3 of the plantar sole 1.

If a plurality of orthesis elements or inserts 4 of different orthesisconfiguration is provided, it is possible to obtain, on a plantar sole,a template or fussbet of whatever shoe (a normal shoe, a sport shoe, anorthopedic shoe), an orthesis configuration which is modifiableaccording to the need of the user because it is formed by orthesiselements or inserts 4 which are removable and repositionable.

FIGS. 4 to 6 show a flat plantar sole or sole 5 formed by three layers,namely, a cardboard layer 6 acting as a supporting surface for the userfoot, an intermediate layer 7 in a plastic material, for examplepolyurethane foam, and a covering 8 in a grasping material of anysuitable type, for example of self-adhesive type to be applied to thelower face of the sole or plantar sole. One or more orthesis inserts 9may be applied to the grasping layer 8, in both the calcaneal zone andthe zones of the foot sole and foot toes, so as to form a desiredorthesis configuration.

For example, each orthesis insert 9 may have a body 10 in elasticallyyielding material and at least one surface 11 covered by a fabric orother material on which the grasping layer 8 can ensure a secureremovable grip.

In this embodiment, the orthesis inserts 9 are designed to be arrangedin correspondence of the face of the plantar sole or sole 5 which, inuse, is beneath so that the orthesis inserts 9 are hidden and can not beseen.

Further orthesis inserts of various anatomic-geometric configuration areshown in FIGS. 7 to 12. The orthesis insert 12 of FIGS. 7 and 8 istypically formed, as the orthesis inserts 4 and 9, by a three-layerstructure, namely, an upper covering layer 13 in fabric, non-wovenfabric, or the like, an intermediate tridimensional layer 14, forexample in elastically yielding material, such as rubber, latex, and thelike, and a lower layer 15 in a grasping material, said layers beingsewn, in case, together along the border of the orthesis insert.

The orthesis insert 16 (FIGS. 9 and 10) has a parallelepipedconfiguration and is formed by two layers: for example, on layer in asemirigid or elastically yielding material 14 and the other layer in agripping material 15.

FIGS. 11 and 12 show an orthesis insert 17 which is configured so as tograsp and interest the whole peripheral band of the calcaneal zone of aplantar sole or sole 17, and has a cross section which is decreasingfrom the periphery to the inside, as shown in FIG. 12.

Obviously, orthesis inserts showing a structure as described above maybe used in various sectors in addition to the podiatric sector, theorthopedic sector and the medico-chirurgical sector, also in theaesthetic sector, sport sector, physiotherapy and rehabilitation sectorand in the shoe industry in general. In the podiatric sector, orthesisinserts according to the invention may be used, for example inconnection with all the problems connected to corns, hyperkeratosis,ingrown nails, and also in all those morbid pathologies and non-morbidpathologies in which it is necessary to modify the posture condition ofthe foot (valgus or varius heel, twisted or supine or prone forefoot)with corrective effect also of anomalies of the lower limbs as concernsthe knee or the femoral rotation, as in the case of a gait with toesturned inwards or outwards, in the case of a varius shinbone, valgus orvarius knee or femoral antinversion.

Concerning the sole of the foot, targeted corrections are possible withimmediate effect on the fore, medial and rear plantalgia. To this end,it is possible to provide map plantar soles or map soles, for example asthose that are shown in the FIGS. 13 to 20.

The structure of a map plantar sole or map sole 20 can be typically thatshown in the FIGS. 13 and 14, in which a multi-layer structure isprovided. More precisely, said multi-layer structure comprises a firstsupport layer which, for example, is formed in turn by a leather die-cut21 and a covering felt layer 22, which are sewn together along theperipheral border of the die-cut or coupled to each other differently,as well as a mapped layer or die-cut layer including three layers,namely a grasping layer 23 tuned toward the covering felt 22 to be fixedto it removably, a layer of soft, rigid or semi-rigid material 24, forexample a plastic material, and a covering layer 25, for example afabric, a felt, and the like.

For purely illustrative, non-restrictive purposes, the mapping as shownin FIG. 16 will be described in detail here below, in which the varioussubdivision areas or islands of the plantar sole are marked with lettersof the alphabet.

The islands “g” to “k” are provided to unload or support the metatarsalheads so as to avoid single or multiple metatarsalgia.

In correspondence of the island I (medial arch), it is possible tosupport or unload the head of the first (g), second (h+m) and third(n+i) metatarsus while in correspondence of the island “o” (lateralforefoot) it is possible to support or unload the third (n+i), thefourth (j) and the fifth (k) metatarsus as well as to correct theeffects of the supination and the effects of all the forefoot anomaliesthat can affect this area of the foot.

The island “r” (medial plantar bend or longitudinal arch) may becorrective, compensative or stimulating for the structure of the plantararch in all the cases, for example, of abnormal foot, hollow foot andflat foot. The island “r” may be associated to the island “I” for aneffective orthesis correction of pathologies of the plantar arch such asyielding, rigidity, hyperextensions and hyperflexions of the first andsecond ray.

The island “s” (central-lateral zone of the medial plantar arch) is thesupporting seat of the base of the fifth metatarsus and can beconveniently unloaded and corrected in case of a pathologic foot or afoot affected in this area by morbid or styloid processes. The island“s” may be advantageously associated to the island “o” for an effectivecorrection of the whole middle-lateral foot by applying suitableorthesis inserts according to the invention.

The island “t” corresponds to the supporting seat of the calcanealapophysis and can act as a discharge to the calcaneal spine for thetreatment of talalgia or heel inflammations and the various pathologiesof the heel, while the islands “u” and “v” correspond to areas of thecalcaneal contour and allow through the insertion of suitable orthesiselements to compensate the asymmetries of the lower limbs as well as theabnormalities of support caused by a valgus or varius heel, variusshinbone, etc.

The island “p” can act as an unloading area for the medial plantalgiaand the supporting seat corresponding to the sinus of the tarsus, or itcan be corrected with an orthesis element in case of sprains ordislocations of all the ankle ligaments.

The island “p” in association with the island “t” allows, for example,to unload the insertions of the plantar muscles and the aponeurosis inthe calcaneal zone.

The island “q” is the separation zone between the middle foot and theforefoot and may be utilized together with the islands “I”, “p” and “r”,or together with the islands “o” and “s”, as reinforcement seat by meansof orthesis medial or lateral inserts or as unloding seat for medial andlateral orthesis correctives.

The islands “a” to “e” are unloading zones for a respective foot toe,while the island “f” may form an unloading zone or a supportinginterdiaphyseal zone for any toe anomaly such as olinodattille,hammertoes, deformed toes.

In order to create an unloading zone in a plantar sole or sole 20, it issufficient to “pull up” (FIG. 15) or remove the corresponding mappingisland or remove a portion of layers 24 and 25 from the grasping layer22, which portion can be, in case, utilized as insert in a neighboringisland or elsewhere in the plantar sole or sole. This possibility oftransposition of the map island involves that a plantar sole or sole 20forms a “kit” of orthesis elements at disposal of the operator who can,therefore, intervene rapidly to personalize the plantar sole or sole inorder to adapt it to the specific requirements of the anomalies orpathologies of the user.

Naturally, the anchoring means of an orthesis insert may be various. Inaddition to the grasping fabrics, said means may include the sewing, theclosing by means of metal points, the hole-peg coupling 26 (FIGS. 17 and18) or the coupling with approaching pegs (type Lego®) or throughadhesion by magnetic attraction and others, the particular type ofanchoring means being not determinant.

However, it is preferable to use anchoring means which allow, ifnecessary, a removal of the orthesis insert so that it can be replacedwith another orthesis element or it can be oriented differently.

The mapping of the orthopedic medical device can be also of the“geometrical” type, with holes, rhombuses, polygonal windows occupied incase by zones incorporating metal elements 31 (FIGS. 17, 18).

The removability of the orthesis elements according to the presentinvention forms a particularly advantageous feature because it makespossible to obtain, in a short time, the optimal orthesis configurationfor the single user or patient while the optimal orthesis configurationcan be often obtained only with successive approximations ofconformation of the inserts and positioning or orienting of the inserts.

Besides being applied on plantar soles and insoles, an orthesis elementaccording to the invention can be applied also to the internal wall ofthe upper or ankle boot of a shoe so that the orthesis element can, forexample, take the configuration of a calcaneal medial or lateralbuttress 30 (FIG. 21), or can be applied to the internal front wall ofski boots for the protection of the shinbone.

In the medical field, orthesis elements according to the presentinvention can be used in decubitus or compression areas creating painfor the patient, and in any case in points where it is necessary toisolate areas to be protected for a rapid rehabilitation of the injuredarea.

In sports, orthesis elements according to the invention can be arrangedinside a helmet, for example for one or more head areas affected bylesions or abnormalities.

In the orthopedic field, orthesis elements according to the inventioncan constitute modifications in general of orthopedic braces,prostheses, and orthopedic articles.

The thickness and the anatomic-corrective conformation of the variousorthesis inserts according to the invention can be the most varied onesaccording to the specific application to which they are designed.

A technician of the sector can provide other modifications or variantswhich are to be considered as included in the scope of protection of thepresent invention.

1-10. (canceled)
 11. Orthopedic medical device suitable for beingapplied to an orthopedic guardian adapted to directly or indirectlycontact an area of a limb or a part of the body to protect, saidorthopedic guardian comprising a face, comprising an orthesis structurehaving at least one external wall to be anchored to the face of theorthopedic guardian.
 12. Orthopedic medical device according to claim11, wherein the orthesis structure comprises at least one external wallto be removably anchored to the face of the orthopedic guardian. 13.Orthopedic medical device according to claim 11, wherein the at leastone external wall comprises a layer of grasping or graspable material,the face of the orthopedic guardian comprising a graspable or graspingmaterial, respectively.
 14. Orthopedic medical device according to claim12, wherein the at least one external wall comprises a layer of graspingor graspable material, the face of the orthopedic guardian comprising agraspable or grasping material, respectively.
 15. Orthopedic medicaldevice according to claim 11, wherein the at least one external wallcomprises removable male or female engaging means, the face of theorthopedic guardian comprising removable female or male engaging means,respectively.
 16. Orthopedic medical device according to claim 12,wherein the at least one external wall comprises removable male orfemale engaging means, the face of the orthopedic guardian comprisingremovable female or male engaging means, respectively.
 17. Orthopedicmedical device according to claim 14, wherein the orthesis structurecomprises an orthesis map with removable zonal ortheses for theformation of anatomical discharges and/or inserts.
 18. Orthopedicmedical device according to claim 17, wherein the orthesis structurecomprises a layered structure consisting of at least one supportinglayer and at least one diecut layer defined by removable islands orzones.
 19. Orthopedic medical device according to claim 18, wherein saidsupporting layer comprises a diecut layer and a covering element in agraspable material, joined to each other, and wherein said diecut layercomprises: a grasping layer turned toward the graspable material of thediecut layer for a removable fixing, a layer of soft or rigid orsemirigid material, a covering layer.
 20. Orthopedic medical deviceaccording to claim 19, wherein said diecut layer and said coveringelement are joined to each other in correspondence of the peripheraledge of the hollow punch.
 21. Orthopedic medical device according toclaim 16, wherein the orthesis structure comprises an orthesis map withremovable zonal ortheses for the formation of anatomical dischargesand/or inserts.
 22. Orthopedic medical device according to claim 21,wherein the orthesis structure comprises a layered structure consistingof at least one supporting layer and at least one diecut layer definedby removable islands or zones.
 23. Orthopedic medical device accordingto claim 22, wherein said supporting layer comprises a diecut layer anda covering element in a graspable material, joined to each other, andwherein said diecut layer comprises: a grasping layer turned toward thegraspable material of the diecut layer for a removable fixing, a layerof soft or rigid or semirigid material, a covering layer.
 24. Orthopedicmedical device according to claim 23, wherein said diecut layer and saidcovering element are joined to each other in correspondence of theperipheral edge of the hollow punch.
 25. Orthopedic medical deviceaccording to claim 20, wherein the orthesis structure is made of a rigidor semirigid material or the orthesis structure is made of anelastically yielding material.
 26. Orthopedic medical device accordingto claim 24, wherein the orthesis structure is made of a rigid orsemirigid material or the orthesis structure is made of an elasticallyyielding material.
 27. Orthopedic medical device according to claim 25,wherein said layers of grasping material, soft, rigid or semirigidmaterial and covering material are bound or coupled together. 28.Orthopedic medical device according to claim 26, wherein said layers ofgrasping material, soft, rigid or semirigid material and coveringmaterial are bound or coupled together.